Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Heart Valve Disease Clinical Trial

— SCOUT-II  

Official title:

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225612
• Other study ID #: CLPR-011
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2017
• Last updated: February 6, 2018
• Start date: May 22, 2017
• Est. completion date: November 2022

Study information

• Verified date: February 2018
• Source: Mitralign, Inc.
• Contact: Patricia Keating
• Phone: 978-863-2445
• Email: pkeating[@]mitralign.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

Description:

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;

• =18 and =85 years old;

• NYHA II, III, or ambulatory IV;

• Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;

• patient is at high risk for open heart valve surgery

• LVEF =35%

• Tricuspid valve annular diameter =55 mm (or 29 mm/m^2)

Exclusion Criteria:

• Pregnant or lactating female;

• Severe uncontrolled hypertension (SBP = 180 mmHg and/or DBP = 110 mmHg);

• Previous tricuspid valve repair or replacement;

• Severe coronary artery disease;

• MI or known unstable angina within the 30-days prior to the index procedure;

• Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;

• Chronic oral steroid use (=6 months);

• Life expectancy of less than 12-months

Related Conditions & MeSH terms

• Chronic Symptomatic Functional Tricuspid Regurgitation
• Heart Valve Disease
• Heart Valve Diseases
• Tricuspid Valve Insufficiency

Intervention

Device:
• Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.

Locations

Country	Name	City	State
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Herzzentrum Brandenburg in Bernau	Bernau bei Berlin
Germany	CardioVascular Center Frankfurt	Frankfurt
Germany	Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH	Hamburg
Germany	Herzzentrum Leipzig - Universitätsklinik	Leipzig
Germany	German Heart Center Munich	Munich
Italy	Ospedale San Raffaele	Milan
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	University Medical Center Groningen	Groningen
Portugal	C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Mitralign, Inc.	CardioVascular Research Foundation, Korea, Genae, Regulatory and Clinical Research Institute

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all-cause mortality at 30 days.	Incidence of all-cause mortality at 30 days.	30-days
Secondary	Technical success	Technical success, defined as freedom from death at 30 days with: successful access, delivery and retrieval of the device delivery system; deployment and correct positioning of the intended device(s) which is maintained and; no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure	30 Days
Secondary	Echocardiographic variable: tenting height (maximum, any view)	Echocardiographic variables assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device	Change from Baseline at 30 days
Secondary	Echocardiographic variable: tenting area (maximum, any view)	Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device	Change from Baseline at 30 days
Secondary	Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)	Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device	Change from Baseline at 30 days
Secondary	Tricuspid regurgitation as determined by echocardiographic methods	As measured by the PISA method and the Quantitative Flow method	Change from Baseline at 30 days
Secondary	Percent tricuspid regurgitation from baseline to 30-days	Percent tricuspid regurgitation from baseline to 30-days	Change from Baseline at 30 days
Secondary	Adverse Events	Rate of adverse events, including serious adverse events	Up to 60 months post procedure
Secondary	New York Heart Association (NYHA) classification	Change in New York Heart Association (NYHA) classification	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Secondary	Six-Minute Walk Test (6MWT)	Change in the Six-Minute Walk Test (6MWT)	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Secondary	Minnesota Living with Heart Failure Questionnaire (MLWHF)	Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
Secondary	EuroQol Five Dimensions Questionnaire (EQ-5D)	Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)	Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure